This chapter explains the risk management approach the Regulator uses to inform decisions on applications for DIR and DNIR licences. The purpose of risk management is to protect the health and safety of people and to protect the environment by controlling or mitigating risk.
Risk management encompasses:
- preparing a risk management plan—includes treating risk, general risk management measures, and draft licence conditions
- monitoring and reviewing—measures to assess the effectiveness of all steps in risk analysis, including post-release review of general/commercial releases of GMOs.
Risk management plan
The risk management plan provides an answer to the question: ‘Can the risks posed by a proposed dealing be managed in such a way as to protect the health and safety of people and the environment?’
Preparation of a risk management plan may be informed by considering a number of general questions, including:
- What are the outcomes of the risk evaluation?
- What measures are available for managing risk?
- How effective are the risk management measures?
- How feasible, practical or compatible are the risk management measures?
- Which treatment measure(s) provide the optimum and/or desired level of management for the proposed dealing?
- Do the risk management measures themselves introduce new risks or exacerbate existing ones?
Consistent with the overarching objective of protection, the Regulator prioritises preventative risk treatment measures over ameliorative or curative ones; that is, the risk treatment measures would be focused on preventing the risk being realised rather than on reducing or repairing the resultant harm.
The risk assessment includes consideration of the causal pathway(s) necessary for any given risk to be realised. This understanding of how dealings with a GMO might result in harm and the nature of the harm provides valuable information for identifying risk treatment options. For example, knowledge of the causal pathway enables identification of points in the chain where treatment may be most easily and/or effectively applied.
While the focus of risk management of moderate and high risks is on treatment measures to prevent risks being realised, attention is also paid to the important questions of ‘What could be done if a particular risk were realised?’ and ‘What actions would need to be undertaken to reduce, reverse or repair damage or harm?’ In considering possible management conditions for dealings that involve moderate or high-risk estimates, it is important to establish if the harm or damage that might result could be reversed, and to identify curative or ameliorative actions as well as preventative measures. For example, if a GMO produced a protein toxic to humans it would be important to establish if a medical treatment existed to treat the toxicity. Such remedial measures should be included in contingency or emergency plans.
Redundancy in risk treatment options, for example by establishing measures that ‘break’ more than one link in a causal pathway, increase the effectiveness of risk management. In such cases, failure of a single risk treatment measure would not necessarily result in realisation of an adverse outcome. For example, a standard preventative condition in transporting GM seeds is double containment, often related to managing a risk of potential weediness. However, even if the double containment were breached and seed spilled, it would be unlikely that the weediness risk would be realised, because clean-up measures would be invoked.
Nevertheless, in some cases, the measures proposed by the applicant may be evaluated as excessive or not required to protect the health and safety of people or the environment. In addition, a measure to manage one risk may introduce a new risk or increase the level of risk. For example, additional personal protective equipment such as a chainmail glove to prevent injury from scalpels or needles reduces dexterity and may lead to increased chance of spills of a GMO in containment.
When a risk is evaluated as requiring treatment, options to reduce, mitigate or avoid the risk are identified and assessed, and selected management measures are implemented through licence conditions. This includes consideration of options to reduce exposure to the GMO or its products, and to restrict opportunities for the spread and persistence of the GMO, its progeny or the introduced genes.
The range of suitable controls and limits will depend on the nature of the:
- proposed dealings
- controls and limits proposed by the applicant
- nature and properties of the organism
- trait (the characteristics of the GMO conferred by gene technology)
- properties, number and location of the introduced genes
- location of the dealings, including proposed type and level of containment (DNIRs), or environmental conditions at the release site (DIRs)
- normal production and management practices.
- be feasible to implement and able to operate effectively in practice
- meet currently accepted requirements for best practice (eg good agricultural practice, good laboratory practice, good clinical practice, good manufacturing practice)
- manage the risks to the level required for the duration of the dealings and period of the licence
- be able to be monitored.
The most appropriate options available to manage the risk are then selected. It is possible to envisage a number of options that may provide different levels of management of a specific risk. Equally, one management strategy may control a number of risks. The Regulator must be satisfied that the risks will be managed by the draft options before a licence can be issued. This may include options that manage the risks most comprehensively and/or those that are judged to provide a sufficient level of management.
Any identified uncertainty in aspects of the risk assessment or risk treatment measures must be addressed in determining the appropriate risk management. Uncertainty in risk estimates may be due to insufficient or conflicting data about the pathways to harm (eg due to climate change) or the likelihood or severity of potential adverse outcomes. Uncertainty can also arise from a lack of experience with the GMO itself. For example, plants (including GM plants) perform differently when grown under ideal growth conditions (such as in glasshouses) compared to performance in the open environment as observed during field trials. Risk treatment measures would be devised to take account of such uncertainty. For instance, the size of a reproductive isolation distance for a field trial of a GM plant would be based on data of the overall distribution of pollen, and not just on the median distance pollen might travel.
In the case of limited and controlled DIRs and some DNIRs, the Regulator assists GMO developers by identifying data that may be needed to assess applications for future proposed releases that are larger in scale and/or have fewer restrictions, as in the case of general/commercial releases. In addition, section 62(2)(h) of the Act allows the Regulator to impose licence conditions to require collection of data or conduct of research if this is considered appropriate to manage risk. The findings of such research may result in changes to licence conditions to better manage risk and will inform future evaluations of the same or similar GMOs.
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General risk management measures
Proposed controls and limits for DIRs and proposed containment measures for DNIRs provide important elements of the risk context against which risks are assessed. In the case of DIRs with GM plants, these containment measures may include specifying physical controls (such as fences), isolation distances, monitoring zones, pollen traps, post-release clean-up and specific monitoring requirements (such as removal of sexually compatible species from the release site). In the case of DNIRs, this includes the level of physical containment and work practices.
The risk management plan considers the adequacy and appropriateness of these proposed measures to restrict the spread and persistence of the GMO such that risks can be managed. This is particularly relevant to limited and controlled DIRs and DNIRs where these measures are intended to compensate for uncertainty or inexperience with the GMO. Therefore, the risk management plan considers whether these measures will be sufficient to contain or restrict the spread and persistence of the GMO. However, these measures are also considered in terms of suitability, necessity and the possibility of introducing additional risks.
Other statutory requirements contribute to the overall management of risk, including:
- suitability of the applicant
- identification of the persons or classes of persons proposed to be covered by the licence
- existence of reporting structures, including a requirement to inform the Regulator if the applicant becomes aware of any additional information about risks to the health and safety of people or to the environment.
The Regulator requires DNIR and limited and controlled release licence holders to have contingency plans in place in case the GMOs are spilled or found where they are not intended. The nature of such plans will vary depending on the licence and nature of the dealings. This includes informing the Regulator if there is an unintentional release of the GMO.
All licences also contain reporting provisions in case of unexpected events occurring or new information becoming available relating to the GMO and the dealings. The licence holder is required to provide regular reports to the Regulator and to report any relevant changes in circumstances, unintended effects, new risks or contravention of conditions.
If new or increased risks associated with the authorised dealings are identified, the Regulator may vary licence conditions or, if necessary, suspend or cancel the licence.
In cases of non-compliance with licence conditions, the Regulator may instigate an investigation to determine the nature and extent of non-compliance (OGTR 2007). If proven, a range of remedies are available that include provision for criminal sanctions of large fines and/or imprisonment for failing to abide by the legislation, conditions of the licence or directions from the Regulator, especially where significant damage to health and safety of people or the environment could result. However, the Regulator seeks to achieve cooperative compliance wherever possible.
Section 62(2)(a–o) of the Act enables the Regulator to impose licence conditions for a range of issues including, for example, the scope of the dealings and actions to be taken in the case of release of a GMO from a contained environment. These licence conditions are imposed as a means of implementing the risk management plan and other statutory requirements. The licence holder is legally required to comply with these conditions. Formulation of clear and unambiguous licence conditions is therefore critical to ensure:
- treatment measures or controls are applied as intended and manage risk effectively
- licence holders understand the specific requirement so compliance with the conditions can be demonstrated
- the Regulator can enforce compliance with the conditions, identify non-compliance and, where necessary or appropriate, undertake remedial and/or punitive actions.
Monitor and review
The purpose of monitoring and reviewing all steps in risk analysis is to ensure the right things are done, each step is done correctly, and the outcomes remain valid in the light of changes in circumstances or new information. A number of both internal and external feedback mechanisms can be used to maintain the effectiveness and efficiency of risk assessment and risk management, while considering the concerns of all interested and affected stakeholders.
Internal processes of monitoring and review include:
- standard operating procedures for specific administrative processes
- internal peer review of DIR and DNIR RARMPs
- merit-based selection processes for OGTR staff
- conflict of interest declarations and procedures for OGTR staff.
- expert scrutiny by GTTAC of certain licence applications and RARMPs
- external scrutiny and review through the extensive consultation processes with Australian Government agencies and the Environment Minister, State government agencies, relevant councils, interested parties and the public on all DIR RARMPs
- oversight by the Legislative and Governance Forum on Gene Technology
- external, independent selection of the Regulator and Advisory Committee members, and Legislative and Governance Forum on Gene Technology agreement on these appointments
- accountability to the Australian Parliament through provision of quarterly and annual reports
- review by administrative appeals mechanisms.
Monitoring and reviewing contribute to identifying situations where treatment measures are not adequately managing the risks, either as a result of control measures not maintaining the effectiveness of the limits imposed or non-compliance, or because of changed circumstances and/or unexpected or unintended effects. They also facilitate ongoing review of the conclusions of risk assessment and of the risk treatment options. Identifying changed circumstances enables a reassessment of the risks posed by the dealings and the treatment measures in the light of experience, and for risk management to be modified where necessary. Such review activities may also provide important information for the risk assessment of subsequent licence applications for the same or related GMOs.
Ongoing oversight provisions
Some general/commercial release DIR licences, particularly those requesting unrestricted release, incorporate a requirement for ongoing oversight in the risk management plans, which may be achieved through identified post-release review activities.
Accordingly, the Regulator may impose licence conditions that require the licence holder to supply or enable the Regulator to collect specific information on the release7. This provides a mechanism for ‘closing the loop(s)’ in the risk analysis process, or for verifying findings of the RARMP, by monitoring specific indicator(s) of harm that would usually have been identified in the risk assessment. Potential ‘triggers’ for this component of post-release review may occur where the risk estimate is greater than negligible, or there is relevant uncertainty (eg lack of consensus among expert advisers).
A second component of post-release review is to collect information on possible adverse effect(s) of released GMOs on human health and the environment. This could result in reports over the short and long term about any DIR licence. Credible information would form the basis of further investigation.
A third component of post-release review is the review of RARMPs at any time after the licence is issued. Such reviews take into account any relevant new information, or may be triggered by findings from either of the other components of the post-release review. The purpose of a review would be to ensure the findings of the RARMP remain current. If the review findings justify either an increase or a decrease in the initial risk estimate(s), or identify new risks to people or to the environment that need managing, this could lead to review of the risk management plan and changes to the licence conditions.
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The risk assessment (Chapter 4) and the risk management plan are essential components of decision making in relation to DIR and DNIR licence applications.
The Regulator, as an independent statutory office holder, is charged with making decisions on issuing licences to authorise dealings with GMOs, which includes imposition of licence conditions. The Regulator also decides on suspending, cancelling, transferring or varying licences. Each of these decisions is based on whether the Regulator is satisfied that any risks posed by the dealings can be managed in such a way as to protect the health and safety of people and the environment.
Although the risk analysis framework described applies to the consideration of all licence applications, there is no one-size-fits-all solution. The Regulator adopts a case-by-case approach, weighing the available evidence against any uncertainty of likelihood or consequence, and the availability of management measures, to arrive at a prudent judgment.
To support the decision-making process for DIR applications, the Regulator must be satisfied that the applicant is a suitable person to hold the licence and must seek advice from the GTTAC and a wide range of agencies and authorities (see Figure A1). In addition, the Regulator can seek advice from the GTECCC, and the Legislative and Governance Forum on Gene Technology may also provide the Regulator with guidance through policy principles, policy guidelines and codes of practice. In relation to DNIR licences, the Regulator may consult the GTTAC, the States, relevant Australian Government agencies, and anyone else the Regulator thinks appropriate.
The steps the Regulator must take into account in the decision-making process for DIRs and DNIRs are provided in Appendix A.
The key factors in making these decisions include:
- setting the terms of reference for the risk assessment
- establishing the risks to the health and safety of people or to the environment that require management
- determining licence conditions that define the scope and boundaries of the proposed dealings and manage the risks.
After a licence is issued it can be varied, suspended or cancelled according to provisions under the Act (sections 68–72). This enables the Regulator to respond to new information or changed circumstances that affect the level of risk.
Monitoring for compliance
Sections 152 and 153 of the Act give the Regulator extensive powers for monitoring compliance with the Act and Regulations. Where risks requiring management have been identified and treatment measures imposed through licence conditions, or in guidelines, monitoring is necessary in order to verify that those treatment measures or obligations are being applied and that risks are being appropriately managed.
Specific monitoring activities to support compliance with the Act and Regulations include:
- routine monitoring of limited and controlled environmental releases and contained dealings
- unscheduled monitoring of limited and controlled environmental releases and contained dealings (spot checks)
- profiling of dealings to aid strategic planning of monitoring activities
- conducting education and awareness activities to enhance compliance and risk management planning of licence holders and organisations
- conducting audits and practice reviews in response to findings of routine monitoring
- performing incident reviews in response to ‘self reported’ non-compliance
- conducting investigations in response to allegations of non-compliance with conditions or breaches of the legislation.
In the case of limited and controlled DIRs for GM plants, post-harvest monitoring continues until the GMOs resulting from the authorised dealings have been removed from the release sites to the Regulator’s satisfaction.
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7Such conditions would be additional to the notification requirements imposed on licence holders under section 65 of the Act (see ‘General risk management measures’).